FDA Adverse Event
Injury
Summary report: N
SERIES TWENTY THOUSAND LEGACY
MDR report key: 252631
·
Received December 2, 1999
Report
- Report Number
- 2028159-1999-00323
- Event Type
- Injury
- Date Received
- December 2, 1999
- Date of Event
- October 6, 1999
- Report Date
- November 3, 1999
- Manufacturer
- ALCON LABORATORIES, INC.
- Product Code
- HQE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTER NOTED SEVERAL INSTANCES OF STERILE INFLAMMATORY PROCESS. SURGERY WAS IN 1999 AND INFLAMMATION WAS DETECTED ON 10/06/1999. PT REPORTEDLY RECOVERED WELL WITH TOPICAL STEROID DROPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERIES TWENTY THOUSAND LEGACY | OPHTHALMIC SURGERY SYSTEM | HQE | ALCON LABORATORIES, INC. | STTL | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Required Intervention |